Summary

at La Jolla, California and other locations
study started

Description

Summary

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

Official Title

Managed Access Program (MAP) to Provide Access to CTL019, for ALL or DLBCL Patients With Out of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification for Commercial Release

Details

The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Keywords

Acute Lymphoblastic Leukemia (ALL) Diffuse Large B-cell Lymphoma (DLBCL) Acute Lymphoblastic Leukemia ALL Pediatric Diffuse Large b-cell Lymphoma DLBCL Adult Relapse Refractory CTL019 tisagenlecleucel Kymriah CART19 CART CAR T cells Chimeric antigen receptor Manufacturing Expanded Access Out of Specification Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

Eligibility

You can join if…

  • Written informed consent must be obtained prior to any screening procedures or treatment assignment.
  • Has a patient specific batch of CTL019 which is out of specification either due to out of specification incoming apheresis or final product not meeting commercial release.
  • Not excluded from commercial manufacturing under the prescribing guidelines for their country
  • Out of specification material has not been deemed to pose an undue safety risk to the patient
  • Is suffering from a serious or life-threatening disease or condition
  • Repeat leukapheresis is not feasible per the treating physician assessment
  • Does not have access to a comparable or satisfactory alternative treatment
  • Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options, the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient
  • Meets any other relevant medical criteria for compassionate use of the investigational product
  • Is not being transferred from an ongoing clinical trial for which they are still eligible

You CAN'T join if...

  • Product can be commercially manufactured per the specification of the country in which treatment will occur.
  • Patients who are able to repeat leukapheresis.
  • Evidence of CD19 negative disease
  • HIV positive patients
  • Patients with active replication of Hep B or active or latent Hep C
  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
  • Uncontrolled active infection or inflammation
  • History of unstable angina or MI within 6 months prior to screening
  • Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment

Locations

  • UCSD
    La Jolla California 92093 United States
  • Rady Childrens - UCSD
    San Diego California 92123 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Novartis Pharmaceuticals
ID
NCT03601442
Study Type
Expanded Access
Last Updated